IPP-ON IPPONINSTP
GUDID 10381780125877
The IPP-ON set includes instruments to be used as a guide for Interphalangeal implants. The interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe.
NEWDEAL
General internal orthopaedic fixation system implantation kit| Primary Device ID | 10381780125877 |
| NIH Device Record Key | a35f8d66-2177-4c0e-b0df-74219b7b1f3a |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | IPP-ON |
| Version Model Number | IPPONINSTP |
| Catalog Number | IPPONINSTP |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780125877 [Primary] |
| HIBCC | M248IPPONINSTP1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103623
FDA Product Code
| HTY | PIN, FIXATION, SMOOTH |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-05-02 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [IPP-ON]
| 10381780125877 | The IPP-ON set includes instruments to be used as a guide for Interphalangeal implants. The inte |
| 10381780045908 | The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixatio |
| 10381780045892 | The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixatio |
Trademark Results [IPP-ON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IPP-ON 79056207 3576532 Live/Registered |
NEWDEAL 2007-12-13 |
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